As you no doubt already know, the Pharmaceutical Industry in Argentina is a strictly controlled industry. Said control is held by the ANMAT Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) and it spreads from the first authorisation of a laboratory to act as such in the country, moving through the authorisations to commercialise products, up to pharmacovigilance of products that have already been commercialised ...
Hunton & Williams is a regional leader in its ability to assist both local and global clients conducting business in Southeast Asia. With an established office in Bangkok, our resident lawyers possess the practical knowledge, global perspective, regional understanding and creative problem solving tools necessary to assist clients in achieving their business objectives in Southeast Asia ...
On February 20, 2014, the Quebec National Assembly passed Bill 28, An Act to establish the new Code of Civil Procedure. This is a watershed moment in a process that began in 2003 and was the subject of a review by the Minister of Justice in 2006. Notably, promoting cooperation by the parties on the conduct of proceedings and increasing reliance on case management conferences are meant to improve access to justice ...
In an opinion that could substantially affect future controlling-shareholder buyouts, the Delaware Supreme Court on Friday affirmed the Chancery Court’s decision that the business judgment standard of review, rather than entire fairness, should apply to controlling-party takeovers where it is established before trial that certain protections exist. Background The suit stemmed from Ronald Perelman’s going-private buyout of M&F Worldwide Corp. (“MFW”), a company he controlled ...
A new Consumer Protection Act is currently in the process of being adopted in Croatia, and has revamped areas of the Act dealing with the sale of products at reduced prices and obligations for public service providers.The new Act imposes traders the obligation to point out two types of prices – regular and reduced. This obligation is related to seasonal reductions in prices, which may be applied up to three times a year and may last no longer than 60 days under the provisions of new Act ...
In one of the few decisions of its kind, the UK High Court recently assessed the damages to be paid to a generic pharmaceutical company under a cross-undertaking in damages. While some aspects of the decision are specific to the UK pharmaceutical reimbursement scheme, the judgment will be a useful reference point for parties involved in similar litigation in Australia ...
Breaking the News: Disclosing Data Breaches and Withstanding Regulatory Scrutiny Breached companies are often crime victims, but they are also potential targets for regulatory actions (and, as we will discuss in future installments, potential parties to a wide range of litigation) ...
Your company’s compliance programme may not be the easiest topic to bring up at an executive management meeting, but it probably is one of the most important. What makes for a good compliance programme? This topic was raised at a Krogerus Compliance Officer Roundtable that gathered a cross-section of business executives in Finland. Here is a summary of some ideas you may wish to keep in mind ...
On February 20, 2014, the Supreme Court of Canada allowed the motion for leave to appeal the judgment of the Court of Appeal of Québec rendered in the case of Theratechnologies inc. v. 121851 Canada Inc.1. In this unanimous judgment, the Court of Appeal decided that a judgment authorizing a class action based on section 225 ...
The Clock is Ticking: Investigating and Responding to a Breach Once your company becomes aware of a suspected data breach, time is of the essence. Losses from the breach are likely mounting, the clock is running on your organization’s legal rights and obligations, and the potential liability to claims by regulators and plaintiffs begins to expand ...
The Fourth Circuit recently held that selling contaminated drugs in violation of FDA regulations does not give rise to False Claims Act liability where compliance with the regulations is not a condition of federal reimbursement. See United States ex rel. Barry Rostholder v. Omnicare, Inc., No. 12-2431 (4th Cir. Feb. 21, 2014) ...
Insurance Coverage for Cyber Attacks: What Do You Need in a Cyber Liability Policy?With more and more businesses suffering costly data breaches and cyber attacks, companies should utilize every tool they have to shift the potentially enormous expenses associated with those breaches and attacks. That’s where insurance comes in ...
Although trust has always been regarded as one of the best succession vehicles, it has never been attractive for the succession of shares in companies because of a rule of English trust law, the “prudent man of business rule”. It was established in the case of Bartlett v Barclays Bank Trust Co Ltd [1980] 1 Ch 515 that it is the duty of a trustee to conduct the business of the trust with the same care as an ordinary prudent man of business would extend towards his own affairs ...
Tailor-Made: Designing and Implementing a Bespoke Data Security Plan When you hear the term “bespoke,” you may think suits or dresses, but you should be thinking data security plans. Savvy organizations realize that there is no “one size fits all” approach to data security ...
The world of networked devices controlling our heating and household energy supplies, monitoring our health, and ensuring our cars do not collide, is now more reality than science fiction. This interconnected world — this ‘Internet of Things’ — promises to transform our lives, probably more than we can presently imagine ...
Investors analysing the possibility to acquire a Chilean corporation should carefully consider the specific structure of corporate control governing most of the legal entities in Chile, since it strongly determines the way mergers and acquisitions are carried out in this country ...
We are seeing a definite upswing in the number of entrepreneurs and start-ups for myriad reasons (including, as one example, the recent enactment of Law 14/2013, of September 27, 2013, to support entrepreneurs and their internationalization). As a result, we have decided to launch a series of posts on the subject of start-ups and the world of the entrepreneur. This first post discusses the shareholders’ agreement because from a legal angle it is one of the cornerstones of any start-up ...
The news has been filled with stories of high-profile data breaches, exposing breached companies to intense and negative scrutiny from lawmakers, regulators, media, customers, and plaintiffs’ attorneys. Other companies that handle personal information have been asking us how they can avoid a similar fate. In the coming weeks, we will be exploring that issue through our special series, "A Desk Guide to Data Protection and Breach Response ...
Welcoming the ASEAN Economic Community in 2015, the Indonesian Government is planning to revise the current Negative List (Presidential Regulation No. 36 of 2010) to create more business opportunities for foreign investors and to improve the nation’s competitiveness. The Investment Coordinating Board (“BKPM”) is currently drafting the New Negative List in coordination with several other relevant government authorities ...
On January 17, 2014 the Bankruptcy Court for the District of Delaware issued a ruling in Fisker Automotive Holdings, Inc., et. al., Case No. 13-13087 (KG), which highlights potential risks to both secured creditors and purchasers of claims in bankruptcy section 363 sales. The facts in Fisker are straightforward ...
On January 17, 2014, the Federal Trade Commission (FTC) announced increased jurisdictional thresholds for premerger notification filings under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act). The FTC adjusts the thresholds annually to reflect changes in the gross national product. The revised thresholds will apply to any transaction closing on or after the effective date, which is 30 days after formal notice is published in the Federal Register ...
On January 9, the US District Court for the Northern District of California found that Bazaarvoice Inc. violated Section 7 of the Clayton Act by acquiring its primary rival, PowerReviews Inc. — launching the new year with a significant merger trial win for the Antitrust Division of the US Department of Justice (DOJ). But, this case also is important for businesses analyzing antitrust risks associated with potential competitor acquisitions ...
Traditionally, the estate administrator’s main duty has been to liquidate the machinery of the estate as quickly as possible. But there are alternative possibilities. Instead of seeing the bankruptcy estate as a pile of assets left behind by a company that has gone through financial hardship, smart thinking says you should see this as an opportunity to start a new business. At its best, bankruptcy means a fresh start for a successor company without burdens of the bankrupt one ...
